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  • FDA issues import alert on Olympus endoscopic devices over quality violations
    The U.S. Food and Drug Administration has issued an import alert for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation and its subsidiaries. The alert applies to…
    fda medwatch · 21d agoRegulatoryNegative↗ source
  • Cardinal Health issues updated instructions for Presource kits containing recalled BD Alaris infusion sets
    The FDA CDRH issued an Early Alert to inform the public of a potentially high‑risk device issue involving Cardinal Health Presource kits that may contain BD Alaris Pump Infusion Sets linked to a re…
    fda medwatch · 21d agoRegulatoryNegative
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  • Nova Biomedical pulls Gen 2.0 StatStrip hospital glucose meters over patient ID software flaw
    Nova Biomedical has issued a recall of its StatStrip Glucose Hospital Meter System Gen 2.0 model after discovering a software issue that could assign glucose results to the wrong patient. The FDA…
    fda medwatch · 21d agoCRLNegative↗ source
  • Epic introduces prescription marketplace to let doctors and patients compare drug prices
    Epic, a leading electronic health record provider, announced a new prescription marketplace designed to help physicians and patients see price differences across pharmacies. The platform integrate…
    Endpoints · 21d agoPositive↗ source
  • Astellas teams up with Boston miniprotein startup to explore AI-designed tiny proteins
    Astellas Pharma announced a partnership with a Boston-based startup that specializes in miniproteins, small engineered proteins that can serve as therapeutic agents. The startup leverages artifici…
    Endpoints · 21d agoDealPositive↗ source
  • Update: Import Alert for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers
    The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus)…
    fda medwatch · 21d ago↗ source
  • Early Alert: Cardinal Health Issues Correction for Presource Packs Containing BD Alaris Pump Infusion Sets
    Cardinal Health Presource Kits containing recalled BD Alaris Pump Infusion Sets should be corrected prior to continued use.
    fda medwatch · 21d ago↗ source
  • Merck KGaA to acquire Silence Therapeutics for $1.3 billion, expanding siRNA portfolio
    Merck KGaA, the German science and technology conglomerate, announced an agreement to purchase UK‑based Silence Therapeutics. The deal is valued at about $1.3 billion and gives Merck access to Sil…
    Endpoints · 22d agoDealPositive↗ source
  • Roche signs up to $15 billion ADC partnership with China's Hansoh, paying $400 million upfront
    Roche announced a new partnership with Chinese drugmaker Hansoh Pharmaceutical Group focused on antibody‑drug conjugates. The agreement includes an upfront payment of $400 million and the potential…
    BioPharma Dive · 22d agoDealPositive↗ source
  • Roche signs $400 million upfront deal with China's Hansoh, potential $15 billion partnership
    Roche announced a major collaboration with Chinese biotech Hansoh, committing $400 million upfront. The agreement gives Roche access to Hansoh's drug discovery platform and aims to co-develop cand…
    Endpoints · 22d agoDealPositive↗ source
  • Merck KGaA to acquire Silence Therapeutics for $1.3 billion, adding Phase-2 RNAi drug for polycythemia vera
    Merck KGaA announced it will purchase UK‑based Silence Therapeutics for about $1.3 billion, paying $20 in cash per share, representing a 130 % premium. The deal gives Merck control of an RNA‑inter…
    BioPharma Dive · 22d agoDealPositive↗ source
  • Disc Medicine reports positive Phase 3 results for bitopertin in erythropoietic porphyria
    Disc Medicine announced that its experimental therapy bitopertin achieved its primary and secondary goals in a Phase 3 trial for erythropoietic porphyria, a rare condition that makes patients extre…
    BioPharma Dive · 22d agoPositive readoutPositive↗ source
  • Gilead to launch Phase 3 trial of oral α4β7 inhibitor after promising Phase 2 ulcerative colitis results
    Gilead Sciences announced plans to begin Phase 3 trials next year for its oral α4β7 integrin inhibitor aimed at treating ulcerative colitis. The move follows a Phase 2 dose‑finding study that repo…
    Endpoints · 22d agoPositive readoutPositive↗ source
  • Antheia secures $80 million conditional loan from DOD to expand U.S. generic drug manufacturing
    Antheia, a biosynthesis manufacturer, has been awarded a conditional loan of $80 million from the U.S. Department of Defense. The funding is aimed at onshoring the company’s generic drug productio…
    Endpoints · 22d agoDealPositive↗ source
  • EyePoint's Phase 3 trial fails, prompting 53% staff cuts; Lilly signs China drug delivery partnership
    EyePoint, a Watertown, Massachusetts biotech, reported that its experimental therapy did not meet primary endpoints in a Phase 3 study, marking a setback for the company. Following the trial failu…
    Endpoints · 22d agoNegative readoutNegative↗ source
  • Disc Medicine's rare sun-sensitivity drug meets all endpoints in Phase 3 trial
    Disc Medicine announced that its experimental therapy for a rare condition that makes sun exposure painful has completed a Phase 3 study. The trial reported success on every primary and secondary…
    Endpoints · 22d agoPositive readoutPositive↗ source
  • Saudi Arabia rolls out biotech partnerships to support its $34.6 billion non‑oil growth plan
    Saudi Arabia’s National Biotechnology Strategy, launched in early 2024, aims to add $34.6 billion to non‑oil GDP by 2040 and create 11,000 jobs by 2030. The plan is now moving beyond policy into co…
    BioPharma Dive · 22d agoPositive↗ source
  • Nouscom secures $135 million Series D to advance lead cancer vaccine into Phase 2
    Clinical-stage biotech Nouscom announced it has closed a $135 million Series D financing round that was oversubscribed. The capital will be used to move its lead cancer vaccine candidate into a Pha…
    Endpoints · 22d agoDealPositive↗ source
  • ESMO 2026 preview spotlights upcoming abstracts from Zai Lab, GSK and Merck
    The European Society for Medical Oncology (ESMO) meeting returns to Madrid in 2026, featuring a slate of abstracts expected from several major biotech and pharmaceutical companies. Among the antic…
    Endpoints · 22d agoNeutral↗ source
  • Sanofi partners with ScionxBio to screen long-acting RNA candidates
    Sanofi has entered into a collaboration with biotech startup ScionxBio to evaluate long-acting RNA candidates. The agreement marks ScionxBio's first partnership since it separated from its former…
    Endpoints · 22d agoDealPositive↗ source
  • Veradermics' oral minoxidil clears late-stage trial endpoints
    Veradermics, a Connecticut‑based biotech, reported that its oral extended‑release formulation of minoxidil, VDPHL01, has completed a late‑stage clinical trial. The drug is a pill version of the wel…
    Endpoints · 22d agoPositive readoutPositive↗ source
  • TriGemX Bio to go public via SPAC to advance migraine drug candidate
    TriGemX Bio, formerly known as Kallyope, said it will become a public company by merging with a special purpose acquisition company. The transaction is aimed at raising capital and accelerating the…
    Endpoints · 22d agoDealNeutral↗ source
  • Massachusetts jury awards former MIT professor David Sabatini $6 million in defamation case
    A Massachusetts jury has ordered a $6 million damages award to David Sabatini, a former professor at MIT and noted biologist. The verdict stems from a defamation lawsuit that Sabatini filed after…
    Endpoints · 22d agoNeutral↗ source
  • Early CDMO engagement: balancing speed with flexibility in CMC planning
    Bringing a new therapy to the clinic requires clinical, non‑clinical, regulatory and CMC activities to move forward together. In early development, having drug material available is often on the cr…
    BioPharma Dive · 22d agoNeutral↗ source
  • Philips issues updated use instructions for Lumify ultrasound systems after software glitch risk
    Philips Ultrasound has sent a letter to customers of its Lumify diagnostic ultrasound system, advising that the devices require updated use instructions. The update addresses a software applicatio…
    fda medwatch · 22d agoCRLNegative↗ source